Actively Recruiting
Psychological Adjustment to Long-term (PAL) Physical Conditions: A Randomised Cross-over Feasibility Trial of a Self-guided App
Led by King's College London · Updated on 2025-09-16
60
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
Sponsors
K
King's College London
Lead Sponsor
A
Avegen Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study. The intervention consists of a self-guided smartphone app (Orbi) based on cognitive behavioural therapy (CBT) principles, which is designed to support psychological adjustment in long-term physical conditions. Orbi is an app adaption of an existing, evidence-based web-based intervention COMPASS. The control condition consists of usual charity support (UCS) for the relevant long-term physical health conditions (LTCs). All charity support includes a helpline which can be accessed via telephone or email. The goal of this trial is to evaluate the feasibility of Orbi and the main questions it aims to answer are: 1. Is Orbi a feasible and acceptable intervention for individuals experiencing psychological distress related to LTCs? 2. Which aspects of the Orbi app and the trial enhance or diminish participants' experiences? Participants will: * Be randomised and each participant has an equal (50 %) chance of being assigned either to the Orbi+UCS group or to UCS group alone for 12 weeks. After 12 weeks, they will be crossed over to the alternate condition for another 12 weeks * Complete questionnaires to assess psychological distress and intervention engagement at baseline, 6 weeks, and 12 weeks. * A subset of participants will be invited to take part in a nested, optional semi-structured interviews to explore their experiences using Orbi and participating in the study.
CONDITIONS
Official Title
Psychological Adjustment to Long-term (PAL) Physical Conditions: A Randomised Cross-over Feasibility Trial of a Self-guided App
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Proficient in verbal and written English
- Resident in the United Kingdom and registered with a General Practitioner
- Have basic computer skills
- Have an email address to register with Orbi
- Have a long-term physical health condition
- Experiencing distress related to their long-term physical condition
You will not qualify if you...
- Evidence of substance dependency, cognitive impairment, or severe mental health conditions as identified by usual care screening
- Severe depression or anxiety indicated by scoring over 6 on the PHQ-4 questionnaire or scoring 1 or above on the PHQ-9 suicide risk question
- Currently receiving active psychological treatment from a psychologist, counsellor, therapist, or online psychological intervention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Health Psychology Department, King's College London
London, London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
R
Rona Moss-Morris, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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